Topiramate Liquid Formulation IND Gets Regulatory Go-Ahead

Scott Boyer, BS, founder and chief executive officer, OWP

Scott Boyer

OWP Pharmaceuticals has announced that the FDA has approved its investigational new drug (IND) application for its first-ever liquid formulation of topiramate, providing a new delivery alternative for the therapy used in epilepsy and migraine treatment.

The company noted that this is the first of several oral suspensions within the neuroscience space which it plans to commercialize in the coming years. OWP also applied for patent protection in the US on the heels of this regulatory decision.

“We believe that clinicians who regularly treat young patients with epilepsy, who often have trouble with or are afraid of swallowing tablets, could benefit from the availability of a liquid formulation of topiramate for which the dose can be fine-tuned and precise,” Scott Boyer, BS, founder and chief executive officer, OWP, said in a statement. “Some parents, who are already troubled with their child’s diagnosis, have challenges with the administration of tablets to their children.”

Topiramate was first granted regulatory approval in the United States in 1996 and has since become a widely used option for clinicians. In oral tablet or capsule form, topiramate accounts for approximately 12 million total prescriptions annually, according to Symphony Health.

It is currently indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older and as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Additionally, it has an indication for the preventive treatment of migraine in patients aged 12 years and older.

“Today marks the achievement of a key milestone in the development of our company’s first liquid oral suspension, which, if approved, would represent the first available oral suspension of topiramate,” Boyer said. “Given that there are no currently available liquid formulations for many drugs in neuroscience that are widely prescribed, we are very excited to have the potential to bring our first suspension for a significant unmet need to the pediatric community, and possibly to other clinicians who have patients that struggle with swallowing tablets, such as in older populations.”

Topiramate has been explored in other formulations as well in epilepsy, as adherence issues due to the challenges in the administration have required alterations to dosing and delivery. Epilepsy has remained a disease plagued by polypharmacy and the aforementioned adherence issues, which can result in breakthrough seizures, drug-drug interactions, and other adverse effects. This has made the prospect of novel formulations a welcome one for clinicians like Rodney Allan Radtke, MD, professor of neurology at Duke University School of Medicine in Durham, North Carolina. In August, Radtke told NeurologyLive that he was skeptical that extended-release formulations change anything in tolerability, “but it seems to have.”

“I do have patients using that who could tolerate a higher dose of the extended-release as opposed to the immediate release,” he explained. “And obviously, patients will more consistently adhere to the once-a-day product.”

REFERENCE

OWP Pharmaceuticals Announces IND Approval and Patent Application for the First-Ever Liquid Oral Suspension Formulation of Topiramate for the Treatment of Epilepsy and Migraine [press release]. Naperville, IL: OWP Pharmaceuticals; Published November 20, 2019. globenewswire.com/news-release/2019/11/20/1950056/0/en/OWP-Pharmaceuticals-Announces-IND-Approval-and-Patent-Application-for-the-First-Ever-Liquid-Oral-Suspension-Formulation-of-Topiramate-for-the-Treatment-of-Epilepsy-and-Migraine.html. Accessed November 20, 2019.